FLOAT Through Anxiety: Examining the Efficacy and Safety of the Virtual Reality Application "Float" as a Tool to Distract From Negative Emotions and Thoughts in People With High Levels of Anxiety and Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- situational anxiety before session
研究概览
简要总结
The goal of this clinical trial is to examine the effectiveness and safety of the VR FLOAT application as a tool to reduce negative thoughts and feelings and anxiety symptoms in students with high levels of stress and anxiety. The main questions it aims to answer are:
- Will subjects with high levels of anxiety who will use the FLOAT application experience a more significant relief in feelings of anxiety compared to subjects in the control group?
- Will subjects who are used to using technology find greater comfort in using VR compared to subjects who are not used to it?
- What is the degree of satisfaction with the use of VR and are there any reports of side effects?Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets Researchers will compare control group to see The comparison between using FLOAT as a regulation strategy after psychoeducation on emotional regulation and cognitive-behavioral use of a regulation strategy after the same psychoeducation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •'moderate' or 'severe' levels of stress and/or anxiety according to the DASS-21 questionnaire
排除标准
- •under the age of 18
- •diagnoses of schizophrenia or bipolar disorder, including past or present psychotic conditions
- •suicidality
- •pregnant women
- •do not speak or read Hebrew fluently
- •a diagnosis of epilepsy.
结局指标
主要结局
situational anxiety before session
时间窗: a week
The State-Trait Anxiety Inventory (STAI) questionnaire. range 20 to 100, with a higher score representing higher levels of anxiety
situational anxiety after session
时间窗: a week
The State-Trait Anxiety Inventory (STAI) questionnaire. range 20 to 100, with a higher score representing higher levels of anxiety
Ease of using the technology
时间窗: week 3, after intervention
System Usability Scale (SUS). scale from 0 to 100. A score higher than 70 indicates good usability, while a score lower than 50 indicates low usability.
satisfaction with life
时间窗: week 3, after intervention
Satisfaction with Life Scale (SWLS). 5 to 35. A high score represents higher life satisfaction and a lower score represents a lower life satisfaction
次要结局
- The FLOAT user experience(week 3, after intervention)
研究者
Yael Enav
Dr. Yael Enav
University of Haifa